CART Therapy in GUCY2C-positive Digestive Tract Tumors

Exclusion Criteria

• •1. T cell transduction efficiency \<5% or T cell amplification \< 2 times after culture;
• •2. Participated in other drug clinical trials within 4 weeks before the start of the study;
• •3. Patients with hypertension and unable to obtain good control by single antihypertensive drugs (systolic blood pressure \> 140 mmHg, diastolic blood pressure b\> 90 mmHg, the specific conditions shall be evaluated by the researchers) have myocardial ischemia or infarction of grade I or above, arrhythmia of grade I or above (including QT interval ≥ 440ms) or cardiac insufficiency;
• •4. A wound or fracture in the chest or other area that has not healed for a long time;
• •5. Has a history of substance abuse and is unable to quit or has a history of mental disorders;
• •6. Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe pulmonary function impairment, etc.;
• •7. Fungus, bacteria, virus or other infection that cannot be controlled or requires antibiotic treatment. The presence of a simple urinary tract infection and uncomplicated bacterial pharyngitis is permitted after consultation with a medical supervisor;
• •8. For subjects who have used chemotherapy before, according to NCI-CTCAE 4.0, there is grade ≥2 hematological toxicity or grade ≥3 non-hematological toxicity at the time of enrollment;
• •9. A known history of HIV, or a positive nucleic acid test for hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive);
• •10. The presence of any indwered catheter or drainage tube (e.g., bile drainage tube or pleural/peritoneal/pericardial catheter). The use of specialized central venous catheters was permitted (the influence of fistula, percutaneous nephrostomy, and indwsed Foley catheters in colorectal cancer patients was considered by the investigators);
• •11. Brain metastases; A history or medical condition of CNS, such as seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS;
• •13\. Significant immunodeficiency; 14. The major therapeutic drugs in this study (including fludalabine, cyclophosphamide, sodium meth, and tozumab and anti-infective drugs used to prevent and treat CRS) have a history of severe hypersensitivity reaction; 15. History of deep vein thrombosis or pulmonary embolism 6 months before enrollment; 16. A history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has resulted in injury to the terminal organs or that requires systemic immunosuppressive/disease-modulating drugs in the past 2 years; 17. Any disease that may interfere with the evaluation of the safety or efficacy of the study treatment.